A Complex Contraception Registry

Sponsor

University of California, San Diego (Other)

Overall Status

Completed

CT.gov ID

NCT02219269

Collaborator

University of California, Los Angeles (Other), University of California, San Francisco (Other), University of California, Irvine (Other), University of California, Davis (Other)

Enrollment

Locations

Actual Duration (Months)

19.4

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators will conduct a prospective observational cohort study to investigate factors that influence contraceptive method utilization among women with medical conditions. The investigators will also investigate how women with medical conditions access to contraception and family planning fellowship trained specialist. After the baseline questionnaire, there be a 3 month and 6 month follow up questionnaire to investigate continuation and satisfaction with the contraceptive method. This study is unique because it will allow us to explore doing collaborative family planning research at the multiple UC medical campuses.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Cardiovascular Disease Epilepsy Migraine Neurological Disorders Cancer Bariatric Surgery Candidate Organ or Tissue Transplant; Complications Lupus Erythematosus, Systemic Other Hematologic Conditions Other Venous Embolism and Thrombosis

Detailed Description

Many women with complex medical conditions who do not desire pregnancy do not receive contraception counseling from their primary or subspecialty care clinicians, and often they are not using contraception. This is an important deficiency as many have conditions that could worsen with pregnancy or for whom pregnancy can be complicated by the medical condition. Thus it is important for women with chronic disease to only become pregnant if they intend to do so. The United States Medical Eligibility Criteria for Contraceptive Use (USMEC), released in 2010, has greatly enhanced the ability of clinicians to counsel patient with complex medical conditions about their contraceptive options. It summarizes the safety of specific contraceptives when used on women with medical conditions. However, little is known about the contraceptive care of these women. We do not know if the availability of the USMEC has translated into evidence-based contraceptive counseling for these women. Further, little is known about their understanding of the interaction between their disease and pregnancy, their past experience and knowledge about contraception, and their contraceptive decision-making, satisfaction and continuation.

The purpose of the Complex Contraception Registry to is to recruit a cohort of women with complex medical conditions who are seen in contraception referral practices run by family planning fellowship trained physicians. We will assess their past experiences and baseline knowledge, their post-counseling experiences and choice of contraception, and their long-term satisfaction with and continuation of contraception. A multi-center registry is necessary because individual institutions see relatively few women with rare diseases such as a history of transplant surgery. The UC Family Planning Collaborative will facilitate recruitment of participants from the 5 UC medical campuses and will oversee their follow-up for one year.

Specific Aim include (1.) To investigate what factors influence contraceptive method utilization among women with complex medical conditions and their perceived risk of unintended pregnancy (2) To investigate how women with complex medical conditions access family planning fellowship trained specialist for contraception counseling and (3.) To assess satisfaction and continuation of contraceptive methods among women with complex medical conditions.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

97 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Complex Contraception Registry - UC Family Planning Collaborative Study

Actual Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Medically complex contraception users Cohort includes women of reproductive age with diverse medical conditions (listed in inclusion criteria) who are referred to Family Planning felowship-trained physicians, seeking contraception counseling and administration.

Outcome Measures

Primary Outcome Measures

Contraceptive method continuation and satisfaction [6 month]
Questionnaire is used to report continued use and satisfaction with multiple choice answer: very satisfied, somewhat satisfied, dissatisfied. Questionnaires will be administered at 3 months and 6 months after recruitment.

Secondary Outcome Measures

History of unintended pregnancy [6 months]
Measured with questionnaire at baseline, 3 months, and 6 months
Change in Medical Condition [6 months]
Measured with questionnaire at 3 months and 6 months
History of contraceptive methods used [6 months]
Measured with questionnaire at baseline
If Contraception is Accessed in post-partum or post-abortion setting [6 months]
Measured with questionnaire at baseline, 3 months, and 6 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Ethnic Background: No limitation, will include minorities
Sexually Active with men
Diagnosis with at least one of the following conditions

Diabetes and other endocrine disorders
Cardiovascular Disease, such as Ischemic Heart Disease, Valvular disease, hypertension or pulmonary hypertension
Epilepsy, Migraine, and other neurologic disorders
History of or current cancer
History of or planning Bariatric Surgery
History of or planning Solid Organ Transplant
Systematic Lupus Erythematous and other rheumatologic conditions
History of or current Venous Thrombosis Embolism
Other Medical Conditions (such as Sickle Cell Disease or Cystic Fibrosis)

Exclusion Criteria:

Pregnant at time of recruitment
History of hysterectomy, bilateral oophorectomy, or sterilization procedure
Unable to provide informed consent
Attempting to become pregnant at time of recruitment
Not sexually active with men
No active telephone number or email for follow up

Women who are pregnant will be excluded from this study. However, no pregnancy testing will be conducted; pregnancy status will be based on self-reporting by subjects.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States	90095
2	UC Irvine	Orange	California	United States	92868
3	UC Davis	Sacramento	California	United States	95817
4	UCSD	San Diego	California	United States	92103
5	UCSF	San Francisco	California	United States	94117

Sponsors and Collaborators

University of California, San Diego
University of California, Los Angeles
University of California, San Francisco
University of California, Irvine
University of California, Davis

Investigators

Principal Investigator: Jody Steinauer, MD, University of California, San Francisco
Principal Investigator: Radhika Rible, MD MS, University of California, Los Angeles
Principal Investigator: Tabetha Harken, MD MPH, UC Irvine
Principal Investigator: Catherine Cansino, MD MPH, UC Davis
Principal Investigator: Sheila Mody, MD MPH, UCSD